DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over LaViola et al. (US 2021/0169579 A1; filed on 12/11/2018) (hereinafter “LaViola”) in view of Snow et al. (US 6,749,554 B1; published on 06/15/2004) (hereinafter “Snow”).
Regarding claim 1, LaViola teaches an ultrasound-detectable (“… made of different materials visible under ultrasound …” [0090]) marker assembly (“FIG. 2A depicts an example biopsy site marker configured in a three-dimensional radial-spoke shape.” [0089]), comprising:
a plurality of individual marker bodies (“… and distal orbs 206 …” [0089]; see Fig.2A), each marker body formed of a non-metallic material having features that is visible in ultrasound image (“The distal orbs 206 may … or made of different materials visible under ultrasound or other imaging modalities such as biocompatible … polymers … or other materials.” [0090]); and
one or more biocompatible (the whole marker is implanted into tissue which inherently requires biocompatible material to meet the regulation requirement; see 21 CFR § 878.4670 - Internal tissue marker) filaments coupling the plurality of individual marker bodies together (“Each radial spoke 204 may be connected to the central orb 202 at a proximal end and may be connected to a distal orb 206 at a distal end.” [0089]).
LaViola fails to explicitly teach that each marker body formed of a non-metallic material having features that generate twinkling artifacts when imaged with Doppler ultrasound.
However, in the same field of endeavor, Snow teaches each marker body formed of a non-metallic material having features ("The outside of the container 2 is coated with a matrix material 3 containing domains of encapsulated bubbles or particles 4." Col.24, Ln.57 - 62; "The matrix material may be a polymer." Col.6, Ln.52 - 67; "Suitable coating materials for use in the invention also include matrix materials such as a fused or melted amino acid ..." Col.7, Ln.14 - 37) that generate twinkling artifacts when imaged with Doppler ultrasound ("In addition, using color doppler ultrasound mode, the presence of active microbubbles on the tube was determined by the flashing colours of bubbles breaking under the influence of the ultrasound energy." Col.30, Ln.54 – 62).
LaViola provides a multi-layered site marker (see LaViola; [0100]) and Snow also provides a similar structure with special coating on a core (see Snow; Col.24, Ln.58 – 62). Both are directed to the problem of visibility in ultrasound imaging.
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the marker as taught by LaViola with the coating material as taught by Snow. Doing so would make it possible to provide “a coating whereby ultrasound visibility of the source is enhanced" (see Snow; Col.4, Ln.62 – 67).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chi Sing et al. (US 2011/0313288 A1; published on 12/22/2011) teach site markers and corresponding localizing technique.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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